Due to inadequacy of data on the effectiveness of medicines regulatory systems in Zambia, this study
was framed. The aim was to evaluate legislative provisions for medicines regulation under three legalregulatory-
frameworks in place over the period from 1995 to 2015. The study was structured in two
distinct phases: the first involved document review of available legislation and secondary data
relevant to the subject matter, covering the study period; the second involved a questionnaire survey
for health practitioners to gather opinions on the effectiveness of the medicines regulatory systems in
Zambia. Assessment of secondary data reported by Ministry of Health, and World Health
Organisation on treatment outcomes and medicines regulation was conducted. Reviewed data showed
relative reduction in incidence of some selected diseases of national importance. It was also evident
that the regulatory systems had improved considerably over the study period. Responses from Health
Practitioners and other players in the health and pharmaceutical sectors indicated that they were aware
of medicines regulatory requirements, supported the need for medicines regulation, and indicated the
need for regional collaboration and increased public awareness raising as means for improving current
medicines regulatory systems. It was recommended that more comprehensive studies be undertaken
to establish causal relationships between medicines regulatory systems, and disease outcomes. A
further recommendation was made to implement more integrated information management systems
in the Ministry of Health, and the Zambia Medicines Regulatory Authority.